FDA Adds Label Warning for Kybella on Neuromuscular and Injection-Site Risks With Unapproved Use
核心洞察
The FDA approved a new Kybella label warning that unapproved injection outside the submental fat region may cause neuromuscular and other serious adverse events.
A FAERS review identified 129 adverse event cases tied to off-region deoxycholic acid use, including blurred or reduced vision with periorbital injection and facial paresis (搜索) or paresthesia (搜索).
The agency also added a warning for unresolved injection-site nodules and masses, with 117 cases present an average of about 143 days after initial or subsequent injections.
The FDA has approved an additional warning in the labeling of Kybella (deoxycholic acid) injection, stating that the product may cause neuromuscular and other serious adverse events when used outside its approved indication, according to a drug safety communication from the agency.
The agency determined that these adverse events may occur when Kybella, marketed by Allergan Aesthetics (搜索), an AbbVie company, is administered outside the submental fat region, the area commonly described as the double chin. The FDA also approved the addition of a warning for the serious risk of injection-site nodules and masses that may not resolve over time and may require medical intervention. These nodules and masses can occur whether patients receive Kybella injections inside or outside the submental fat region.
Evidence Behind the Label Change
The FDA's decision was supported by a review of reports from the FDA Adverse Event Reporting System, now known as the FDA Adverse Event Monitoring System, and evidence from medical literature.
In that review, the agency identified 129 cases of adverse events associated with Kybella injections outside the submental fat region since the product's approval in 2015. Reported serious adverse events included blurred or reduced vision with periorbital use and muscle or nerve injury, including facial paresis (搜索) and paresthesia (搜索).
The review also identified 117 cases of unresolved nodules, defined as growths 3 cm or smaller, and masses, defined as growths larger than 3 cm, associated with these injections. These nodules and masses had been present for an average of approximately 5 months, or 143 days at the time of reporting, and occurred after either an initial or a subsequent Kybella injection.
Approved Indication and Dosing
Kybella was approved in 2015 for the improvement in the appearance of moderate to severe fullness associated with submental fat in adults. It is an injection used to dissolve fat under the chin. Patients can receive up to six injections with each treatment, up to a maximum of 50 injections administered at least 1 month apart. The product is not approved for the treatment of subcutaneous fat outside of the submental region.
At the time of approval, the FDA emphasized that Kybella is only approved for the treatment of fat occurring below the chin and that it is not known whether the product is safe or effective for treatment outside this area. The most common side effects noted at approval were swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area. In clinical trials, some patients developed nerve injury in the jaw that caused facial muscle weakness, asymmetrical facial expressions, and trouble swallowing after injection of deoxycholic acid.
Prior Safety Communications
The new labeling action follows earlier FDA warnings about unapproved fat-dissolving products. In a 2023 safety communication, the agency warned against use of unapproved fat-dissolving substances sold online with promises to reduce fat deposits in areas of the body such as the chin, back, thighs, upper arms, and stomach. That communication highlighted reports of painful knots, permanent scars, and serious infections after use of unapproved injectable fat dissolvers.
Guidance for Clinicians
The FDA instructed healthcare workers to review the prescribing information before injecting Kybella and to advise patients to seek medical attention if they experience signs of marginal mandibular nerve paresis (搜索), difficulty swallowing, or serious injection site reactions.
Deoxycholic acid injections are also available in some markets, including South Africa, under local brand names and alternative fat-dissolving formulas such as DesoFace or general lipolytic and Cecarelli solutions, rather than under the branded Kybella name.